GRA CMC Specialist

The position of GRA CMC Specialist at CSL focuses on shaping worldwide regulatory chemistry‑manufacturing‑control (CMC) approaches for large‑scale capital and compliance initiatives. The role sits within the Global Regulatory Affairs CMC group and works closely with R&D, Quality, Operations and other business units to align strategy with the company’s plasma‑derived therapy portfolio. Day‑to‑day duties involve crafting global CMC plans in partnership with functional leaders, evaluating and introducing digital tools—including artificial‑intelligence and machine‑learning solutions—to streamline submission and intelligence workflows, and establishing performance metrics to gauge efficiency gains. The specialist also oversees external service providers, coordinating timelines, deliverables and compliance across multiple regions while continuously monitoring quality and risk. Keeping abreast of evolving regulations from agencies such as the FDA, EMA, PMDA and NMPA, the individual disseminates updates internally, supports change‑control processes, due‑diligence activities for potential deals, template management for quality sections, and provides assistance during inspections. In addition, the role contributes to policy‑shaping efforts with CSL’s Corporate & External Affairs team and advises senior leaders on regulatory implications for project planning and new business evaluation. Candidates must hold a bachelor’s qualification in a biological, chemical or related discipline, with a graduate degree (MS or PhD) viewed favorably. At least five years of progressive regulatory experience in the biologics or plasma sector, deep familiarity with international drug‑product regulations, and a proven record of preparing and